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Abstract:

A method is provided that includes providing a monitoring apparatus
including one or more modules within a target cavity or lumen of a body.
The one or more modules are provided within the target cavity or lumen in
a first state in which the monitoring apparatus is configured to remain
within the target cavity or lumen. The method further includes monitoring
physiological conditions of the body using one or more sensors within the
one or more modules, and providing the one or more modules in a second
state in which the monitoring apparatus is configured to exit the target
cavity or lumen.

Claims:

1. A monitoring apparatus comprising:one or more modules configured to be
provided within a target cavity or lumen of a body,wherein said one or
more modules is configured to continuously monitor physiological
conditions of the body, andwherein said one or more modules are
configured to be provided in a first state in which said monitoring
apparatus is configured to remain within the target cavity or lumen, and
a second state in which said monitoring apparatus is configured to exit
the target cavity or lumen.

2. The monitoring apparatus according to claim 1, wherein said one or more
modules are configured to be provided in a third state in which said
monitoring apparatus is configured to be inserted within the target
cavity or lumen.

3. The monitoring apparatus according to claim 1, wherein said one or more
modules includes a plurality of modules connected in series, wherein said
plurality of modules are configured to be curved and locked into a ring
shape to provide said first state, and wherein said plurality of modules
are configured to separate from one another to provide said second state.

4. The monitoring apparatus according to claim 1, wherein said one or more
modules are configured to transform into said second state based upon a
signal generated from a component within said one or more modules.

5. The monitoring apparatus according to claim 1, wherein said one or more
modules includes a module configured to wirelessly transmit and receive
communications from an external device provided outside of the body.

6. The monitoring apparatus according to claim 5, wherein said one or more
modules are configured to transform into said second state based upon a
signal from the external device.

7. An apparatus comprising:a delivery portion; anda detachable portion
comprising one or more modules configured to be provided within a target
cavity or lumen of a body, wherein said one or more modules is configured
to continuously monitor physiological conditions of the body,wherein said
delivery portion is configured to lock said detachable portion in a first
state in which said detachable portion is configured to remain within the
target cavity or lumen, and release said detachable portion within the
target cavity or lumen in said first state, andwherein said detachable
portion is configured to have a second state in which said detachable
portion is configured to exit the target cavity or lumen.

8. The apparatus according to claim 7, wherein said one or more modules
are configured to be provided in a third state in which said detachable
portion is configured to be inserted within the target cavity or lumen
using said delivery portion.

9. The apparatus according to claim 7, wherein said one or more modules
includes a plurality of modules connected in series, wherein said
plurality of modules are configured to be curved and locked into a ring
shape to provide said first state, and wherein said plurality of modules
are configured to separate from one another to provide said second state.

10. The apparatus according to claim 7, wherein said one or more modules
are configured to transform into said second state based upon a signal
generated from a component within said one or more modules.

11. The apparatus according to claim 7, wherein said one or more modules
includes a module configured to wirelessly transmit and receive
communications from an external device provided outside of the body.

12. The apparatus according to claim 11, wherein said one or more modules
are configured to transform into said second state based upon a signal
from the external device.

13. A method comprising:providing a monitoring apparatus including one or
more modules within a target cavity or lumen of a body, wherein the one
or more modules are provided within the target cavity or lumen in a first
state in which the monitoring apparatus is configured to remain within
the target cavity or lumen;monitoring physiological conditions of the
body using one or more sensors within the one or more modules;
andproviding the one or more modules in a second state in which the
monitoring apparatus is configured to exit the target cavity or lumen.

14. The method according to claim 13, wherein the monitoring apparatus is
implanted within the target cavity or lumen with the one or more modules
in a third state in which the monitoring apparatus is configured to be
inserted into the target cavity or lumen.

15. The method according to claim 14, wherein the monitoring apparatus is
implanted within the target cavity or lumen using a delivery portion,
wherein the monitoring apparatus is detachably attached to the delivery
portion in the third state during implantation into the target cavity or
lumen, wherein the delivery portion is used to transform and lock the
monitoring apparatus into the first state within the target cavity or
lumen, and wherein the delivery portion is used to detach the monitoring
apparatus from the delivery portion within the target cavity or lumen.

16. The method according to claim 13, wherein the one or more modules
includes a plurality of modules connected in series, wherein the
plurality of modules are curved and locked into a ring shape to provide
the first state, and wherein the plurality of modules are configured to
separate from one another to provide the second state.

17. The method according to claim 13, wherein the one or more modules are
provided into the second state based upon a signal generated from a
component within the one or more modules.

18. The method according to claim 13, wherein the one or more modules
includes a module that is configured to wirelessly transmit and receive
communications from an external device provided outside of the body.

19. The method according to claim 18, further comprising receiving a
signal at the module from the external device, wherein the one or more
modules are provided into the second state based upon the signal received
from the external device.

20. The method according to claim 18, further comprising transmitting data
regarding the monitored physiological conditions of the body to the
external device from within the target cavity or lumen.

Description:

CROSS-REFERENCE TO RELATED APPLICATION

[0001]The present application claims priority to U.S. Provisional
Application No. 61/131,448, filed on Jun. 9, 2008, the entire contents of
which are herein incorporated by reference.

BACKGROUND OF THE INVENTION

[0002]1. Field of the Invention

[0003]The present invention relates to physiological monitoring.

[0004]2. Discussion of the Background

[0005]Atrial Fibrillation (AF) is a common cardiac arrhythmia that is
estimated to affect at least 2.2 million patients in the United States.
Patients suffering from AF have a two to seven times higher risk of
stroke, and the disease has been reported to account for approximately
fifteen percent of all strokes that occur nationally. Currently, there
exist a variety of treatments for AF. These include rate or rhythm
control medications, cardioversion, and the catheter ablation of
arrhythmogenic regions inside the heart.

[0006]The human heart normally beats between sixty to one-hundred beats
per minute when a person is at rest. In AF, the heart's electrical
signals do not travel through normal pathways, but instead spread
throughout the atria in a rapid and disorganized fashion, which in turn
can cause the atria to activate in a chaotic fashion.

[0007]The onset of cardiac arrhythmia may be accompanied by physical
symptoms. For instance, common symptoms in AF patients may include
palpitations, an irregular fluttering sensation in the patient's chest,
shortness of breath, dizziness, or a sudden feeling of weakness.
Nevertheless, it is also common for physical symptoms to be absent during
the onset of certain arrhythmic episodes, and in such cases, these
asymptomatic cardiac arrhythmias, though serious, may go unnoticed by the
patients.

[0008]One of the difficulties associated with the follow-up of AF
treatment procedures lies in accurately assessing the long-term burden of
AF in patients. Long-term (i.e. greater than 1 month) follow-up of a
patient's cardiac rhythm is crucial for the optimal management of AF
patients, with regard to the assessment of treatment efficacy and to the
potential discontinuation of anticoagulation therapy. Currently,
physicians do not have any means of gathering detailed information over
an extended period of time regarding the true burden of AF in patients
that will enable them to accurately determine the success of a treatment
procedure in patients.

[0009]Known monitoring devices have not been able to fully address this
problem of long term and continuous cardiac monitoring. One such approach
to this problem involves the use of a "cardiac event monitor." This
solution includes the use of a portable electrocardiography (ECG)
recording device that is carried by the patient and communicates with one
or more wired electrodes that are worn under the patient's clothing, and
are adhesively attached to the patient's skin. The device records the
heart's electrical activity at the push of a button. Patients trigger the
device when they first begin to feel signs or the onset of physical
symptoms that signal an "event", such as dizziness, weakness,
palpitations or lightheadedness. The device is also capable of storing
the patient's cardiac rhythm by recording a rolling "window" of ECG data,
which can later be transmitted over phone lines for review by a qualified
physician. One example of a cardiac event monitor is described in U.S.
Pat. No. 7,117,031.

[0010]Unfortunately, the cardiac event monitor does not adequately address
the need for long-term and continuous monitoring of a patient's cardiac
rhythm during follow-up of a treatment. Current cardiac event monitors
can only be worn for up to a period of thirty days, and removal of the
device is required during certain patient activities such as swimming or
bathing. This in turn renders the device as not being truly continuous in
its monitoring of cardiac arrhythmia events. Second, because patients may
undergo asymptomatic recurrences of their arrhythmia, the reliance of the
event monitor on detecting only symptomatic episodes in patients (i.e.,
symptom triggered recordings) can result in inaccuracies during
determination of the true effectiveness of a treatment.

[0011]Furthermore, it is often cumbersome for the patient to have to be
constantly connected to a set of wires and chest electrodes throughout
the day, and the device can be difficult for many patients to integrate
into their active lifestyle. Finally, the continuous attachment of sticky
electrodes to the patient's chest tends to cause skin irritation, which
further exacerbates the issue of poor patient compliance.

SUMMARY OF THE INVENTION

[0012]The present invention advantageously provides a device that can be
advanced, placed, detached and implanted into one or more body lumens or
cavities to perform internal diagnostic or therapeutic functions.

[0013]In one embodiment of the invention, the device can be used for
continuous monitoring and/or recording of a person's physiological
signals (e.g., heart rate, cardiac electrical activity, heart sounds).
Additionally, an embodiment of the present invention can advantageously
provide a delivery portion that enables the advancing of the entire
device through one or more body lumens and/or cavities. Furthermore, an
embodiment can advantageously provide a user-controlled mechanism for
detaching a detachable portion of the device from the entire device
structure such that the detachable portion of the device can be placed
and implanted within a body lumen or cavity. Also, an embodiment of the
present invention can advantageously provide a user-controlled mechanism
for deactivating the detachable portion of the device after it has been
implanted for a given duration. Additionally, an embodiment of the
present invention can advantageously communicate with an external device
that can download, process, and store the sensed information from the
device and transmit the data to a remote healthcare provider or user.

[0014]One of the purposes of the present invention is to overcome at least
some of the problems described above in connection with the lack of
long-term continuous monitoring of post-AF treatment success by providing
a way in which both symptomatic and asymptomatic atrial fibrillation
events can be sensed and recorded for an extended period of time.

[0015]In a preferred embodiment of the present invention, the detachable
portion of the device comprises of a series of two or more modules that
are connected together. These modules can be linked together by flexible
interconnecting structures such that the entire device can be advanced
easily and navigated within hollow body lumen(s). Upon placement into the
target body lumen, the device can be shaped by the user and locked into a
rigid form or state. Delivery of the device into the target body lumen
can occur through a natural orifice, such as the person's mouth, nose or
rectum. When the device is delivered to the target body lumen, it will be
detached from the entire device structure through a mechanical release
that can be user-controlled and/or triggered.

[0016]When the detachable portion of the device is implanted within the
body lumen, the activation of the device can occur either automatically
or be triggered by the user. In a preferred embodiment of the present
invention, activation is automatically triggered upon deployment of the
detachable portion of the device. After activation, one or more sensors
contained within the modules can begin recording and sensing
physiological signals. In a preferred embodiment, the device will be used
to detect the occurrence of atrial fibrillation events through recording
of heart sounds. In other embodiments of the present invention, sensors
within the device can detect a variety of different physiological signals
for a variety of different conditions. Examples of such physiological
signals that can be detected can include cardiac electrical activity,
temperature, flow rate measurements, chemical substrates and/or
molecules, arterial pulsations with pressure measurements, and arterial
pulsations using pulse oximetry. In a preferred embodiment of the device,
a microphone will be used to detect and record heart sounds from within
the stomach cavity.

[0017]In order to maintain long-term monitoring, the detachable portion of
the device is configured to remain within the target body lumen to
prevent the transit of the capsule through the rest of the
gastrointestinal (GI) tract. During the period of placement within the
body lumen, an external device can periodically or continually, and
wirelessly receive transmitted information regarding the sensed
information. This external device can process, store and further analyze
the information. In a preferred embodiment of the present invention, this
external device can take the form of a portable home base station or
device such as a cellphone. This information can then be transmitted to a
remote user or a healthcare provider in order to assess the AF burden of
a patient through a variety of methods including, but not limited to,
telephony and direct electronic transfer.

BRIEF DESCRIPTION OF THE DRAWINGS

[0018]A more complete appreciation of the invention and many of the
attendant advantages thereof will become readily apparent with reference
to the following detailed description, particularly when considered in
conjunction with the accompanying drawings, in which:

[0019]FIG. 1 is a schematic diagram of a delivery system for a monitoring
apparatus and showing a partial, enlarged view of the monitoring
apparatus, according to an embodiment of the invention;

[0020]FIG. 2 is a schematic diagram of a delivery method for a monitoring
apparatus using radio-opaque markers, according to an embodiment of the
invention;

[0021]FIG. 3 is a schematic diagram of a delivery method for a monitoring
apparatus where the monitoring apparatus is formed into a ring-like
structure, according to an embodiment of the invention;

[0022]FIG. 4 is a schematic diagram of a delivery method for a monitoring
apparatus where the monitoring apparatus is mechanically released and
deployed into a body cavity, according to an embodiment of the invention;

[0023]FIG. 5 is a schematic diagram of a monitoring apparatus sensing
physiological signals, according to an embodiment of the invention;

[0024]FIG. 6 is schematic diagram of a monitoring apparatus transmitting
data to an external device, according to an embodiment of the invention;

[0025]FIGS. 7(a) and 7(b) are schematic diagrams of a monitoring apparatus
showing user-controlled deactivation of the monitoring apparatus,
according to an embodiment of the invention; and

[0026]FIGS. 8(a)-8(g) are schematic diagrams of an entire cycle including
implantation, usage, and deactivation of a monitoring apparatus,
according to an embodiment of the invention.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS OF THE INVENTION

[0027]Embodiments of the present invention will be described hereinafter
with reference to the accompanying drawings. In the following
description, the constituent elements having substantially the same
function and arrangement are denoted by the same reference numerals, and
repetitive descriptions will be made only when necessary.

[0028]The present invention provides a device that can be advanced,
placed, detached and implanted within body lumens or cavities to collect
and/or analyze physiologic data near to or from within body lumens or
cavities, such as the gastrointestinal (GI) tract.

[0029]In the following description, various aspects of a preferred
embodiment of the present invention will be described along with other
possible variations in embodiments.

[0030]Reference is now made to FIG. 1, which illustrates a delivery system
for a monitoring apparatus and showing a partial, enlarged view of the
monitoring apparatus, according to an embodiment of the invention.

[0031]In a preferred embodiment of the present invention, the device
comprises two main components: a delivery portion 10 and a detachable
monitoring apparatus portion 20.

[0032]In a preferred embodiment, the delivery portion 10 and the
detachable portion 20 are advanced through a natural orifice into the
gastrointestinal tract of the patient until a target body lumen is
reached. For example, in a preferred embodiment of the present invention,
the device is advanced through the patient's nose through the esophagus
into the patient's stomach cavity, as shown in FIG. 1. In other
embodiments, the device can be advanced through other natural orifices
such as the patient's mouth, nose, colon, or vagina. Alternatively, the
device can be advanced through endovascular approaches through blood
vessels such as veins or arteries. The device can be advanced into a
variety of different body lumens or cavities, such as the lungs, heart,
blood vessels, colon, GI tract, intestines, etc.

[0033]The delivery portion 10 of the device comprises of a flexible
structure that allows for the easy advancement of the device the through
body lumens and cavities. In a preferred embodiment of the present
invention, the delivery component can take the form of a tubular-like
structure preferably made of a material that remains innocuous to the
tissues of the GI tract and the target body lumen. An example of a
suitable material is silicon rubber.

[0034]FIG. 1 shows a partial, enlarged view of the detachable monitoring
apparatus portion 20 in a state in which the detachable portion 20 can be
inserted within a target cavity or lumen. The detachable portion 20
includes a series of modules that are flexibly interconnected to enable
the advancement of the device through body lumens and cavities. The
modules can contain a variety of different elements that can be used to
sense and/or record physiologic data, or to perform subsequent analysis
of the data recorded, or to communicate with remote device(s). For
example, in the embodiment depicted in FIG. 1, the detachable portion 20
contains a sensing and/or recording module 22, a power source module 24,
a processing module 26, a data storage module 28, and a
transmitter/receiver module 30. In a preferred embodiment of the present
invention, the series of modules are electrically connected to one
another in order that data and information can be communicated between
each module and another module within the series of modules. Other
methods of communication can include Bluetooth, wireless transmission,
infrared transmission, radiofrequency transmission, etc.

[0035]Reference is now made to FIG. 2, which shows the advancement of the
device into the stomach of the patient through the nose. Successful
delivery of the device can be determined through the use of fluoroscopy
to visualize the presence of radio-opaque markers that can lie anywhere
along the entire device structure. In a preferred embodiment of the
present invention, a first radio-opaque marker 40 is provided at a
proximal end of the detachable portion 20 of the device, and a second
radio-opaque marker 42 is provided at a distal end of the detachable
portion of 20 the device. The markers 40 and 42 allow a surgeon to
monitor the advancement of the device through he patient's body, and to
determine when the detachable portion 20 is properly positioned within
the target cavity or lumen of the patient's body.

[0036]In other embodiments of the present invention, successful delivery
of the device can be determined through one or more of the following
means: the use of light emitting fluorescent dye; audio signals like
beeping sounds or alarms that can be triggered by a detected pH level;
magnetic guidance of the device as it is advanced into the target body
lumen or cavity.

[0037]Reference is now made to FIG. 3, which shows a delivery method for a
monitoring apparatus where the monitoring apparatus 20 is formed into a
ring-like structure 50, according to an embodiment of the invention. In
this embodiment, the detachable portion 20 of the device is shaped by the
surgeon and locked preferably into a rigid ring-like structure 50. By
forming the detachable portion 20 into a ring-like structure or state,
the ring-like structure can ensure that the detachable portion 20 remains
within the target body cavity or lumen during a period of time in which
it is desired that the monitoring apparatus perform physiological
monitoring, for example, by preventing the detachable portion from
travelling further down through lower portions of the GI tract, which
have a diameter less than that of the ring-like structure.

[0038]In a preferred embodiment of the present invention, a distal end of
the delivery portion 10 is mechanically attached to a proximal end of the
detachable portion 20 through a mechanical fastening/releasing mechanism.

[0039]Reference is now made to FIG. 4, which shows a delivery method for a
monitoring apparatus where the monitoring apparatus 20 is mechanically
released and deployed into a body cavity, according to an embodiment of
the invention. After the detachable portion 20 of the device has been
locked in the ring-like shape or state, then deployment of the detachable
monitoring apparatus portion 20 into the target body lumen occurs through
a user triggered mechanical release or detachment from the delivery
portion 10. For example, a surgeon can use a triggering device (not
shown) at a proximal end 12 of the delivery portion 10 to release a
mechanical fastening/releasing mechanism at a distal end 14 of the
delivery portion 10 in order to release the detachable portion 20 in the
target cavity or lumen.

[0040]In various embodiments of the present invention, the delivery
portion 20 of the device can include, but is not limited to, the
following forms: a guide wire; a shape memory alloy material; a string or
rope-like structure; a series of wires; a chain-like structure; a series
of modular segments like pills or beads.

[0041]Alternative embodiments of the present application can utilize
different deployment means that do or do not utilize a delivery portion
20. For example, the device can include an expandable structure contained
within a pill capsule that can be swallowed by the patient and dissolved
within the target body lumen to release the contained monitoring
apparatus that can expand into an amorphous or pre-defined shape or state
upon release. By expanding within the target body cavity or lumen, the
expandable structure or state can ensure that the device remains within
the target body cavity or lumen during a period of time in which it is
desired that the monitoring apparatus perform physiological monitoring,
and, after that time, the expandable structure can be deactivated into a
deflated state to allow the monitoring apparatus to exit the body, for
example, by natural means through the GI tract.

[0042]As shown in detail in FIG. 1, the detachable portion 20 of the
device preferably comprises of a series of modules that are flexibly
interconnected to enable the advancement of the device through body
lumens and cavities. Each of the modules, 22, 24, 26, 28, and 30, can be
configured to contain a different element used to allow the device to
sense and/or record physiologic data, as well as to perform subsequent
analysis of the data recorded. Additionally, in a preferred embodiment of
the present invention, the series of modules are electrically connected
to one another in order that data and information can be communicated
between each module and other module(s) within the series of modules.
Other methods of communication can include Bluetooth technology, wireless
transmission, infrared transmission, radiofrequency transmission, etc.

[0043]The shape or locked-states of the detachable portion 20 of the
device can be a variety of forms and structures. In a preferred
embodiment of the present invention, as shown in FIGS. 3 and 4, for
example, the shape of the detachable portion 20 is in the form of a
ring-like structure or state 50 that is of appropriate dimensions in
order to prevent obstruction to the GI tract. Other types of shapes or
locked-states that the detachable component can be shaped in the form of
include spherical, oval, donut-like, rectangular, patch-like, flat,
curved, etc.

[0044]In addition, the shape of the various modules of the detachable
portion 20 can include a variety of shapes and sizes. In a preferred
embodiment, the modules 22, 24, 26, 28, and 30 are shaped in the form of
pill capsules. Other embodiments can include spherical structures, oval
structures, square structures, rectangular structures, etc.

[0045]Reference is now made to FIG. 1, which shows the modular components
of the detachable portion 20.

[0046]The detachable portion 20 of the embodiment shown in FIG. 1 includes
a sensing and/or recording module 22 that includes sensing and/or
recording elements. Such sensing and recording elements can be contained
within one or more of the modular segments to collect physiologic data
from within the body lumen or cavity.

[0047]Reference is now made to FIG. 5, which shows a monitoring apparatus
sensing physiological signals, according to an embodiment of the
invention. In FIG. 5, a sensing and recording module of the monitoring
apparatus 20 is used to sense and record cardiac sounds 60 for a heart 62
of a patient. In a preferred embodiment of the present invention, the
sensing and recording module includes a recording element in the form of
a microphone that is contained within the module 22 to record and detect
cardiac sounds in order to detect the number and duration of atrial
fibrillation events. In another embodiment of the present invention, the
sensing and recording module includes a sensor contained within the
module 22 that includes an electrode that can detect cardiac electrical
activity. Other methods of sensing cardiac rhythm can also include
detection of arterial pulsations with pressure measurements from a
pressure transducer, and detection of arterial pulsations using pulse
oximetry.

[0048]It will be appreciated that a plurality of sensor element types can
be used in the recording/sensing module 22 depending on the type of
physiologic data being collected. These sensor element(s), can refer to
any element suitable for sensing and/or recording data prevailing near or
in the body lumen (e.g. GI tract), and that are capable of being appended
to or included within the module. Examples of these sensor element(s) can
include other acoustic sensors, pressure sensors, motion sensors, flow
sensors, accelerometers, position sensors, infra-red sensors, optical
detectors, electrical resistance sensors, electrical current sensors,
electrical voltage sensors, etc.

[0050]Additionally, one or more of the modules in the detachable portion
20 can also include a sensor that can detect environmental changes to
provide location or positional information. In another embodiment of the
device, this sensor can be a pH sensor that can provide location
information in tracking the capsule as it travels through the patient's
body lumen or GI tract by sensing the environmental pH of the GI tract.

[0051]The detachable portion 20 of the embodiment shown in FIG. 1 further
includes a power source module 24. The detachable portion 20 of the
device can be powered by a power source within power source module 24
that can provide power to any electrical elements within the various
modules of the detachable portion 20, such as the sensing and/or
recording components within module 22. In a preferred embodiment of the
device, the power source within module 24 is in the form of a
rechargeable battery. Other examples of power sources that can be used to
power the device can include: one or more batteries; lithium ion
batteries; high density chemical batteries; high efficiency
micro-batteries; removable batteries; electrochemical cells;
super-capacitor storage units; fuel cells; metabolically driven cells; or
any other suitable electrical power source.

[0052]The detachable portion 20 of the embodiment shown in FIG. 1 further
includes a processing module 26. The processing module 26 in the
detachable portion 20 of the device contains a signal processing system
that can apply a variety of signal processing tools to the data recorded
by the sensing/recording module 22. In a preferred embodiment, the
processing module 26 can apply a series of noise filters to filter out
one or more sources of noise in the acquired signal. Examples of noise
that can be filtered include extraphysiological noises, breath sounds, GI
peristalsis sounds, movement sounds, and any unrelated artifacts which
can interfere with interpretation of the data.

[0053]In a preferred embodiment of the present invention, the processing
module 26 also analyzes the sensed/recorded data for atrial fibrillation
events. This is preferably accomplished through the one or more of the
following ways: detection of atrial contraction heart sounds (e.g. S4);
variability in the amplitude of the S1 heart sound; S2 heart sounds;
detection of heart rate. In other embodiments of the invention, the
processing module 26 can also perform analysis of an atrial fibrillation
event through the detection of cardiac electrical activity, flow
measurements, imaging of the heart.

[0054]In another embodiment of the present invention, the processing
module 26 can perform one or more processing functions which can also
include data analysis, extraction of heart rate and heart sound
information.

[0055]The detachable portion 20 of the embodiment shown in FIG. 1 further
includes a data storage module 28. The physiological data collected by
the sensor/recording module(s) 22 can be stored in raw or processed
format within a data storage component located within a data storage
module 28 of the device, so that further external download and assessment
can be performed.

[0056]In a preferred embodiment of the present invention, data acquired by
the sensing/recording module 22 will be transferred to the data storage
module 28 and stored using a data storage unit, such as a Secure Digital
High Capacity (SDHC) flash memory drive housed within the module 28, with
the option of transmitting the data to an external device. In alternate
embodiments, the data reception and storage components within the
processing module 26 and the storage module 28 can be of another
configuration. For example, the data processor unit and data processor
storage unit can include magnetic data storage, optical storage,
non-volatile computer memory, DRAM, SRAM, compact flash memory, SDHC
flash memory, semiconductor memory chips.

[0057]The detachable portion 20 of the embodiment shown in FIG. 1 further
includes a transmitter/receiver module 30. In a preferred embodiment of
the present invention, one of the modules, namely module 30, in the
detachable portion 20 contains an internal transmitter and/or antenna
unit for the transmission of the collected data from the
sensing/recording module 22 to a receiving unit. The transmitter/receiver
module 30 can also control the activation of the sensing/recording
components in the module 22 to a receiving unit. The transmitter of the
transmitter/receiver module 30 can also control the activation of the
sensing and recording elements within module 22 through communication
with the other modules.

[0058]A suitable transmission component within module 30 can be any type
of short-range or long-range wireless transceiver and/or transmitter that
can communicate with an external transmitter and/or receiver unit of an
external device that preferably outside of the body of the patient.
Additionally in a preferred embodiment of the present invention, the
transmitter/receiver module 30 can also receive data and control commands
from the external device as described below.

[0060]FIG. 6 is schematic diagram of a monitoring apparatus 20
transmitting data to an external device 70, according to an embodiment of
the invention. In a preferred embodiment of the present invention, the
physiological data collected by the detachable portion 20 can be
downloaded to an external device 70 for storage as well as further
processing and analysis. The data can be downloaded through several
different modes. In a preferred embodiment, the data is downloaded to the
external device 70 through the use of a wireless transmission 72, such as
a Bluetooth transmission. Other alternate embodiments can use a variety
of transmission mechanisms, which can include radiofrequency
transmission, infrared transmission, wireless transmission, etc.

[0061]The processed data from the external device 70 can be sent to a
remote user or healthcare provider through one or more modes of
communication. A suitable mode of transmitting this data can include
electronic transmission over the internet. Other variations in
communication can include direct electronic transfer, telephony, wireless
transmission, etc. In another embodiment, the data can be transferred to
a microprocessor found in handheld, workstation, or laptop computer. The
data can also be further assessed by a healthcare professional in a
remote location to determine if the person is experiencing atrial
fibrillation which will require further medical intervention.

[0062]FIGS. 7(a) and 7(b) are schematic diagrams of a monitoring apparatus
showing user-controlled deactivation of the monitoring apparatus,
according to an embodiment of the invention. FIGS. 7(a) and 7(b) show a
user-controlled triggering mechanism of deactivation of the detachable
portion 20. A user (e.g., doctor, nurse, patient, etc.) can deactivate
the detachable portion 20 and terminate monitoring at the end of a
monitoring period or at any point in time.

[0063]The detachable portion 20 of the device can be deactivated through
one or more mechanisms. In a preferred embodiment of the present
invention, the detachable portion 20 of the device is deactivated through
a user controlled mechanical cutting of interconnecting links between the
different modules 22, 24, 26, 28, and 30. For example, a user can trigger
the release of a mechanical cutting tool from within the various modules
by sending a wireless signal 74 from an external device 70 to the
transmitter/receiver module 30 of the detachable portion within the body
lumen. This allows the modules 22, 24, 26, 28, and 30 to split apart into
individual pill capsules 80, as can be seen in FIG. 7(a), and in this
state the capsules 80 are allowed to exit the stomach and pass through a
lower portion 82 of the GI tract, as can be seen in FIG. 7(b), to be
removed from the patient's body.

[0064]Other embodiments for user-controlled deactivation of the detachable
device can include a wired or wireless signal that causes a
heat-triggered deactivation, a light-triggered deactivation, a
pH-triggered deactivation, or a sound triggered deactivation, for
example, such a deactivation signal can be sent from one of the modules,
such as sensing/recording module 22 or processing module 26, to the other
modules. In another embodiment, automatic deactivation of the detachable
device can occur through the timed degradation of biodegradable
interconnecting structures between the modules, for example, such a
deactivation signal can be sent from one of the modules, such as
sensing/recording module 22 or processing module 26, to the other
modules.

[0065]FIGS. 8(a)-8(g) are schematic diagrams of an entire cycle including
implantation, usage, and deactivation of a monitoring apparatus,
according to an embodiment of the invention. FIGS. 8(a)-8(g) contain
stepwise schematic diagrams of an embodiment of a method of use of the
device, where FIG. 8(a) corresponds to FIGS. 1 and 2, FIG. 8(b)
corresponds to FIG. 3, FIG. 8(c) corresponds to FIG. 4, FIG. 8(d)
corresponds to FIG. 5, FIG. 8(e) corresponds to FIG. 6, FIG. 8(f)
corresponds to FIG. 7(a), and FIG. 8(g) corresponds to FIG. 7(b).

[0066]The device in the form of a flexible delivery tube portion that is
mechanically attached to the detachable device portion is first advanced
through an orifice, such as a patient's nose or mouth, through their
esophagus, and into the stomach cavity, as shown in FIG. 8(a). Once
within the stomach, the detachable portion, which is comprised of one or
more interconnecting modules, is locked in the shape of a ring as shown
in FIG. 8(b), and then mechanically released from the delivery portion of
the device and deployed into the stomach cavity as shown in FIG. 8(c).
Inside the stomach cavity, the device is able to sense and record various
physiological conditions, such as cardiac sounds from the heart as shown
in FIG. 8(d), and process the data recorded. Additionally, the device can
also transmit data to an external device for download and further
processing, as shown in FIG. 8(e). Deactivation of the device can occur
through a user-triggered signal that is communicated to the device, for
example from an external device as shown in FIG. 8(f), to activate the
mechanical cutting of the interconnecting region between modules. This
allows the device to break apart into individual modules (see, FIG. 8(f))
that can then travel along the GI tract as shown in FIG. 8(g) through
natural peristaltic motion and out of the person's body.

[0067]While the invention has been discussed with reference to cardiac
monitoring, one or more aspects of the invention would be applicable to a
wide variety of physiological monitoring in addition to those described
in the exemplary embodiments.

[0068]It should be noted that the exemplary embodiments depicted and
described herein set forth the preferred embodiments of the present
invention, and are not meant to limit the scope of the claims hereto in
any way. Numerous modifications and variations of the present invention
are possible in light of the above teachings. It is therefore to be
understood that, within the scope of the appended claims, the invention
can be practiced otherwise than as specifically described herein.